[A clinical study of leflunomide and methotrexate therapy in psoriatic arthritis]

To evaluate the efficacy and safety profile of methotrexate (MTX), leflunomide (LEF) and low-dose MTX and LEF (MTX + LEF) combined treatment for psoriatic arthritis (PsA).

This was a 24 weeks, two-center, open-labeled, controlled trial. All subjects fulfilled the moll and wright criteria for definite PsA. Subjects were given one of the 3 regimens, MTX, or LEF, or MTX + LEF. The primary end point was proportion of psoriatic arthritis response criteria (PsARC) response. The secondary end point was proportion of modified 20% improvement of American College of Rheumatology (ACR20) response.

At week 24, the percent of patients achieving PsARC in MTX, LEF and MTX + LEF group were 75.0%, 68.8%, 83.3% respectively, and the percent of patients achieving ACR20 were 66.7%, 50.0%, 83.3% respectively. At week 24, tender joint counts, swollen joint counts, patient's assessment of pain, patient's global assessment (PGA), physician's global assessment, health assessment questionnaire (HAQ) were significantly improved compared with base-line values (P < 0.05). At week 24, the improvement of patient's assessment of pain, HAQ, ESR were better in the MTX + LEF group compared with LEF group while the improvement of patient's assessment of pain, PGA, HAQ, ESR were better in the MTX group compared with LEF group (P < 0.05). The incidence of treatment related adverse events was 38.5%, 38.9% and 35% in MTX, LEF and MTX + LEF group respectively. There was no serious adverse reactions.

Low dose MTX + LEF regimen showed similar good efficacy and safety profile for PsA patients.